Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial)

Background: Hemodialysis arteriovenous fistulas (AVFs) are the preferred vascular access for patients on hemodialysis. In the Hemodialysis Fistula Maturation Study, 43.7% of the patients achieved unassisted maturation of their fistula without needing an intervention. Venous neointimal hyperplasia (VNH) and subsequent venous stenosis (VS) is responsible for lack of maturation. There are no therapies that can prevent VNH/VS formation. The goal of this paper is to present the background, rationale, and trial design of an innovative phase 1 / 2 clinical study that is investigating the safety of autologous adipose derived mesenchymal stem cells (AMSCs) delivered locally to the adventitia of newly created upper extremity radiocephalic (RCF) or brachiocephalic fistula (BCF). Methods: The rationale and pre-clinical studies used to obtain a physician sponsored investigational new drug trial (IND) are discussed. The trial design and endpoints are discussed. Results: This is ongoing trial which will complete this year. Conclusion: This is a phase 1 / 2 single center, randomized trial which will investigate safety and efficacy of autologous AMSCs in promoting maturation in new upper extremity AVFs.